- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609212
TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery (TLIP-RLB-QoR)
Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial
This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Despite advances in surgical techniques, lumbar spine fusion is associated with significant postoperative pain, which may delay recovery and increase opioid consumption.
Recent approaches emphasize multimodal analgesia and opioid-sparing strategies, including regional anesthesia techniques. Interfascial plane blocks, such as TLIP and retrolaminar block, have gained attention due to their safety and effectiveness in targeting the dorsal rami of spinal nerves supplying the posterior spinal structures.
The primary outcome of this study is postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to ambulation, time to oral intake, and postoperative complications.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a prospective, randomized, controlled, double-blind clinical trial conducted at Assiut University Hospital. A total of 70 adult patients scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia will be enrolled and randomly allocated into two equal groups.
Patients in Group T will receive ultrasound-guided thoracolumbar interfascial plane (TLIP) block, while patients in Group R will receive ultrasound-guided retrolaminar block. All blocks will be performed after induction of general anesthesia under strict aseptic precautions by an experienced anesthesiologist.
Randomization will be performed using a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. The study will be conducted in a double-blind manner, where patients and outcome assessors will be blinded to group allocation.
All patients will receive standardized perioperative care based on enhanced recovery principles, including multimodal analgesia and early mobilization. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and rescue analgesia will be administered when needed.
The primary outcome is the QoR-15 score at 24 hours postoperatively. Secondary outcomes include pain scores at predefined intervals, time to first rescue analgesia, total opioid consumption, time to ambulation, time to oral intake, length of hospital stay, and incidence of postoperative complications.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
- Phone Number: +201063303791
- Email: rehab.mohamed19@gmail.com
Study Contact Backup
- Name: Mohamed Abo Elhassan, MD (candidate)
- Phone Number: +201001311044
- Email: Aboelhassan@gmail.com
Study Locations
-
-
-
Asyut, Egypt
- Assiut University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18-65 years
- Male and female patients
- Scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia
- ASA physical status I-III
- BMI < 35 kg/m²
- Willing to participate and provide informed consent
Exclusion Criteria:
- Patient refusal to participate
- Coagulopathy or anticoagulant therapy
- Infection at the site of block injection
- Known allergy to local anesthetics
- Chronic opioid use (>3 months)
- Severe hepatic, renal, or cardiac dysfunction
- Neurological deficits interfering with pain assessment
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Thoracolumbar interfascial plane Block Group
Patients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia.
|
Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
|
|
Experimental: Retrolaminar Block Group
Patients will receive ultrasound-guided retrolaminar block after induction of general anesthesia.
|
Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
Time Frame: 24 hours postoperatively
|
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated 15-item patient-reported outcome measure.
Scores range from 0 to 150, with higher scores indicating better postoperative recovery.
The primary endpoint is the QoR-15 score at 24 hours after surgery.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity using Visual Analog Scale (VAS)
Time Frame: 30 minutes, 2, 6, 12, and 24 hours postoperatively
|
Pain will be assessed using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
|
30 minutes, 2, 6, 12, and 24 hours postoperatively
|
|
Time to first rescue analgesia
Time Frame: Within 24 hours postoperatively
|
Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).
|
Within 24 hours postoperatively
|
|
Total nalbuphine consumption
Time Frame: 24 hours postoperatively
|
Total amount of nalbuphine administered within the first 24 hours after surgery (mg).
|
24 hours postoperatively
|
|
Time to first ambulation
Time Frame: From end of surgery to first ambulation, assessed up to 48 hours postoperatively
|
From end of surgery to first ambulation, assessed up to 48 hours postoperatively
|
|
|
Time to tolerate oral intake
Time Frame: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
|
From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
|
|
|
Length of hospital stay
Time Frame: From surgery until hospital discharge, assessed up to 7 days postoperatively
|
From surgery until hospital discharge, assessed up to 7 days postoperatively
|
|
|
Incidence of postoperative complications
Time Frame: Within 24-48 hours postoperatively
|
Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).
|
Within 24-48 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLIP-RLB-QoR-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of ManitobaUnknown
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
Clinical Trials on Thoracolumbar interfascial plane block
-
Fayoum UniversityCompleted
-
Samsun UniversityRecruitingAcute Pain | Spinal StenosisTurkey (Türkiye)
-
Bursa City HospitalRecruitingPostoperative Pain ManagementTurkey (Türkiye)
-
Bursa City HospitalNot yet recruitingPain, PostoperativeTurkey (Türkiye)
-
Tanta UniversityCompletedQuadratus Lumborum Block | Thoracolumbar Interfascial Plane Block | Local Anesthetic Infiltration | Lumbar Spine FixationEgypt
-
Indonesia UniversityCompletedAnalgesia | Surgical Procedure, UnspecifiedIndonesia
-
Tokat Gaziosmanpasa UniversityCompleted
-
Medical University of South CarolinaCompletedHealthyUnited States
-
Tanta UniversityUnknownPostoperative Pain | Erector Spinae Plane Block | Ultrasound | Lumbar Laminectomy | Thoracolumbar Interfascial Plane BlockEgypt